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SACCSCAN - personalising clinical management of major psychiatric disorders

Periodic Reporting for period 1 - SACCSCAN (SACCSCAN - personalising clinical management of major psychiatric disorders)

Reporting period: 2016-07-01 to 2016-12-31

At least 1 in 5 of us experience mental health problems during our lifetime but up to 50% of patients don’t receive adequate care. Treatments are available that allow patients to resume normal functioning in society but clinicians are struggling to make accurate diagnosis, match therapy to condition, and provide timely care. Currently, when patients’ symptoms and behaviour don’t meet the criteria set out in the diagnostic manual, it may take up to 10 years to diagnose major psychiatric disorders such as schizophrenia, bipolar disorder and major depression. Delays in receiving a diagnosis can significantly impede delivery of the most effective treatment plan, exposing the patient to risk of further deterioration in well-being, reduction in quality of life leading to job loss, family breakdown, and self-harming. Mental ill health is now recognised as the largest cause of short and long term disability worldwide costing the global economy US$2.5T in 2010 (€798 billion in Europe), with a projected increase to over US$6T by 2030, a CAGR of 7.0%.

Following publication of the latest American psychiatric association’s diagnostic manual (DSM-5) in 2013 and the European equivalent ICD-10, two major impediments to progress in psychiatry received widespread attention. First, the diagnostic approach to date is based solely on patient history, symptoms and observed behaviour. Second, there are no objective tests on the market with sufficient sensitivity, specificity and stability required of clinico-diagnostic value at the level of the individual patient.

SaccScan is a novel point-of-care (PoC) software diagnostic system which has been demonstrated to detect schizophrenia with better than 95% accuracy and can been extended with the same precision to bipolar disorder and major depression illnesses. The test can be performed within 30 minutes and results produced over the internet at near real-time speed. Built on existing eye tracking technology, and access to proprietary clinical reference databases, the software diagnostic system successfully utilises eye-movement abnormalities as clinical diagnostic biomarkers for serious mental illnesses.

The overarching objective of the overall innovation project is validation and maturation of the SaccScan eye movement biomarker test for major psychiatric illnesses. The overall innovation project will deliver a minimum viable product with the necessary regulatory market approvals for Point-of-Care diagnosis at the level of the individual patient by 2020. The purpose of this feasibility study was to deliver an elaborated business plan supported by 1) a feasibility report on the technical viability of the machine learning system which underpins the SaccScan technology; 2) an evaluation on the health economic benefits to all stakeholders including patients, practitioners and health care providers; and 3) a detailed assessment of the market potential for SaccScan.

The conclusions from the feasibility report 1) confirmed the technical viability of SaccScan and identified improvements to complete a minimum viable product for market adoption; 2) confirmed the significant economic advantages for end users e.g. savings in the region of € 40,000 per patient over a 10 year period from improved treatment pathways in the case schizophrenia alone; and 3) confirmed the market potential for SaccScan in excess of € 100 million per annum when fully deployed to all key market segments worldwide over a 10-year horizon.
During the Horizon 2020 SME Instrument Phase 1 Feasibility project, we carried out 3 main activities to produce an elaborated business plan.

1) We completed a technical feasibility assessment to validate the machine learning system for psychiatric disorder classification which underpins the SaccScan technology to inform our product maturation strategy in Phase 2. The study allowed us to identify the remaining technical challenges to be addressed in Phase 2 including system optimisation, process automation, and user friendly diagnostic report generation, to complete a minimum viable product for market adoption in the shortest possible time in the most cost-effective way. The work was informed the design of our field validation strategy for Phase 2. On the basis of this technical feasibility work we won the Horizon 2020 SME Innovation Associate award worth €121,250 to employ a highly-skilled and experienced non-national researcher for 12 months to support us with our product maturation efforts – one of only 71 companies from 17 countries to be selected for this pilot to share a €7 million fund.

2) We completed a health economic assessment to evaluate the business case for end users to adopt SaccScan. The goal of this task is to prepare a preliminary health economic assessment report to demonstrate the assumable future health economic benefit of SaccScan with the focus on schizophrenia, bipolar disorder and major depressive disorder within the German market. The German market is a good representation of other high income markets such as the rest of Europe, North America, Middle East, Japan and Australasia. The strategy is to confirm the economic attractiveness of SaccScan in one market in the first instance with the view of studying other markets in Phase 2 following a positive outcome in Phase 1. The results of the study showed: a) cost savings from adopting SaccScan in the case of schizophrenia alone is € 40,000 per patient over a 10 year period from improved treatment pathways; b) reduced duration to diagnosis i.e. 75% faster for schizophrenia, 95% faster for bipolar disorder, and 90% faster for major depression; and c) avoidable costs due to misdiagnosis through early intervention using SaccScan were estimated at €350 million per annum for schizophrenia, €1.2 billion per annum for bipolar disorder and 1.4 billion per annum for major depression.

3) We completed a detailed market assessment to inform a measured commercialisation plan for Phase 2 and Phase 3 of our overall innovation project. The results of a key stakeholder analysis led us to identifying a) potential end users, b) supply chain partners and c) introduction to investors across Europe through InvestHorizon which was also facilitated by engaging with the SME Instrument Coaching services and events organised by Enterprise Europe Network. The results of this detailed market assessment helped us to secure an Innovate UK Global Cooperation Study award worth €25,000 which will allow us to meet key stakeholders in the supply chain who will engaged further in Phase 2.
No objective test is currently available for major psychiatric disorders. The current gold standard is based on interviewing patients over several months or years to document their behaviour and symptoms with misdiagnosis occurring up to 50% of the time. Improving diagnosis of mental illnesses is a key EU health challenge highlighted in the recent ROAMER study recommending better diagnosis for mental disorders as a priority for Horizon 2020.

SaccScan uses a multi-test approach which can accurately (>95% combined sensitivity and specificity) predict in the data set whether an individual with an eye movement deficit has schizophrenia, or is unaffected, in under 30 minutes, and can be extended to bipolar disorder and major depression. SaccScan will supplement current symptom based diagnoses. It will aid medical research groups with rapid stratification of patients and controls for their clinical studies; aid clinicians in hospitals with differential diagnosis of schizophrenia, bipolar disorder, major depression; and aid primary care providers to distinguish between serious and mild cases to assist with referrals. Although abnormalities of eye movements were first observed in unmedicated psychotic patients over 100 years ago , they have never been considered sensitive or specific enough to be of diagnostic value at the level of the individual patient, and as a result, the observations have been ignored and neglected. Modern eye tracking devices and sophisticated analytical techniques have reinvigorated interest in the potential of eye movements to assist psychiatrists and healthcare professionals.

In addition to the benefits concerning direct healthcare costs of early diagnosis and treatment of psychiatric disorders using SaccScan, the social and economic aspect of early intervention also plays an important role when considering new treatments or diagnostic tools for psychiatric disorders. The scientific literature clearly outlines that shorter duration of untreated psychosis or depression correlate with better health outcomes and thus, in less absenteeism and presenteeism. Furthermore, the quality of life of patients increases as accurate diagnosis and treatment results in better response to the treatment.
Saccade Diagnostics Limited